MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problems Bent (1059); Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

If explanted, give date: not applicable, cartridge is not an implantable device.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the intraocular lens (iol) was stuck inside a 1mtec30 cartridge and the cartridge tip was bent when they opened the carton.No additional information was provided.

Manufacturer Narrative

Device available for evaluation?: yes, returned to manufacturer on 08/22/2017.Device returned to manufacturer?: yes.Device evaluation: the cartridge was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed scarce amounts of residue of what appears to be viscoelastic at the beginning of the cartridge tube.Viscoelastic residue was not observed in the loading zone of the cartridge.The cartridge tube was observed with a bump in where the lens is stuck.The complaint was verified however the complaint could be related to the scarce amount of viscoelastic used.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6832508
• MDR Text Key: 84076879
• Report Number: 2648035-2017-01575
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 15050474540320
• UDI-Public: (01)15050474540320(17)180519(10)CC05983
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/19/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC05983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1